Sanofi-aventis announced that its anticancer drug Taxotere (docetaxel) has received priority review for a new indication by Ministry of Health, Labour and Welfare (MHLW) of Japan. A supplemental New Drug Application (sNDA) as a treatment of metastatic hormone refractory prostate cancer (mHRPC) was submitted to MHLW on Feb. 28 this year.
Since being approved in 2004 in the US and Europe, Taxotere, in combination with prednisone, has become the standard treatment for mHRPC. In large overseas clinical studies, Taxotere-based regimens have conferred longer survival and improved quality of life compared to other active regimens. Yet, currently, there are a limited number of drugs with health insurance coverage, which are used to treat mHRPC in Japan. For that reason, Japanese urologists requested that Japan Society of Clinical Oncology, The Japanese Urological Association, and Japanese Society of Medical Oncology, solicit MHLW to perform a fast review for Taxotere in the prostate cancer treatment.
In Japan, Taxotere is used for the treatment of 7 types of cancer. Taxotere has been approved for the treatment of breast cancer and non-small cell lung cancer as the first taxoid antitumor agent in 1996. Furthermore, it obtained the approval for gastric, head and neck, and ovarian cancers in 2000 followed by esophageal cancer in 2004 and endometrial cancer in 2005.